FDA’s DCT draft guidance: A hit or miss?
The much-anticipated draft guidance on DCTs is here, however, it might have missed several important points on delegation and data management.
03 July 2023
03 July 2023
The much-anticipated draft guidance on DCTs is here, however, it might have missed several important points on delegation and data management.
If approved, datopotamab deruxtecan would provide non-small cell lung cancer patients with an alternative treatment to chemotherapy.
QurAlis will leverage Unlearn.AI’s machine learning algorithms to create digital twins of patients enrolled in clinical trials for amyotrophic lateral sclerosis (ALS).
More than 95% of infants maintained their ability to feed by mouth and swallow up to month 48.
According to the trial findings, dotinurad was found to be safe and well-tolerated.
First results of the Phase II clinical trial are anticipated early next year.
The trial will evaluate patients at 3 months, 6 months and 9 months post-surgical implantation for its 3D printed interbody device.
The company plans to read-out initial data from the trial in 12-18 months.
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